Cognitive Changes Associated With Breast Cancer Treatment
NCT ID: NCT00550134
Last Updated: 2021-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
53 participants
OBSERVATIONAL
2007-10-24
2021-12-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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1, Non Cancer group
A noncancer control group (N=35), frequency matched on age (\< 50 and ≥ 50) and education (less than college or some college and above) will also be recruited and evaluated with the same neuropsychological test battery on a schedule that matches the inter-test interval of the patients.
Questionnaires, MRI, Comet assay and Cell senescence
Neuropsychological and psychological testing MRI, Comet assay and Cell senescence
2 Breast Cancer Patients Scheduled for chemotherapy
We will recruit patients with localized breast cancer undergoing adjuvant chemotherapy for the first time and will test the effects of chemotherapy will be given a battery of neuropsychological tests and an MRI evaluation prior to beginning chemotherapy and approximately one month (plus/minus 4 weeks) following completion of treatment.
Questionnaires, MRI, Comet assay and Cell senescence
Neuropsychological and psychological testing MRI, Comet assay and Cell senescence
3 Breast Cancer Patients Not Scheduled for Chemotherapy
We will recruit patients with localized breast cancer not undergoing adjuvant chemotherapy.
Questionnaires, MRI, Comet assay and Cell senescence
Neuropsychological and psychological testing, MRI, Comet assay and Cell senescence
Interventions
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Questionnaires, MRI, Comet assay and Cell senescence
Neuropsychological and psychological testing MRI, Comet assay and Cell senescence
Questionnaires, MRI, Comet assay and Cell senescence
Neuropsychological and psychological testing MRI, Comet assay and Cell senescence
Questionnaires, MRI, Comet assay and Cell senescence
Neuropsychological and psychological testing, MRI, Comet assay and Cell senescence
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient is female
* Patient is able to understand English, through verbal and written communication
* In the judgment of the investigator and/or the consenting professional patient is able to provide informed consent
* Patient has a diagnosis of breast cancer (stage 0, I, II or IIIA-C), limited to localized disease,
* Patient is chemotherapy naïve and is receiving chemotherapy or is scheduled to receive no chemotherapy as part of adjuvant treatment
* Patient does not report history of prior breast or other cancer with the exception of non-melanoma skin cancer and/or participants who completed treatment for a previous cancer at least 5 years ago and have not undergone any chemotherapy.
* Patient is able to undergo MRI scanning (verified with pre MRI Safety Screening form),
* Patient can comfortably fit inside the MRI machine, verified by back to chest measurement no more than 10 inches or bust circumference of no more than 48 inches.
* Participant is 18 years of age but not older than 70 years of age,
* Participant is female
* Participant is able to understand English, through verbal and written communication
* In the judgment of the investigator and/or the consenting professional participant is able to provide informed consent
* Patient is able to undergo MRI scanning (verified with pre MRI Safety Screening form)
* Patient can comfortably fit inside the MRI machine, verified by back to chest measurement no more than 10 inches or bust circumference of no more than 48 inches.
Exclusion Criteria
* Patient has a history of neurological disorder with cognitive symptoms (e.g., Alzheimer's disease, Parkinson's disease, multiple sclerosis)
* Patient is Pregnant as confirmed by urine pregnancy test. Participants who are post menopausal or have had a hysterectomy do not need a pregnancy test
* Patient is currently on daily medication for migraine or, insulin-dependent diabetes requiring administration by injection,
* Patient has uncontrollable hypertension as per self report or as documented in the medical record
* Patient has a reported fear of enclosed spaces (Claustrophobia)
* Patient has any of the following items that preclude fMRI evaluation
* Cardiac pacemaker, Joint replacements, Aneurysm clips, Transdermal patched, Aortic clips, Prosthesis, Intracranial bypass clips, Harrington rod , Coronary Artery bypass clips, Biostimulator, Renal Transplant Clips, Bone or joint pins, Other vascular clips or filters, Tissue expander ,Implanted neurostimulators, Metal mesh, Artificial heart valve, Stents, Insulin pump, Wire structures, Electrodes, Shrapnel/bullets, Hearing Aids implant, Implanted electrical devices, IUD, Metal in eyes, Shunts, Ocular Implants, Hair extensions, Hair implants, Tattoos above the waist, Any possible metal in body
* Patient has dentures, body jewelry or wig that they are unable to remove
* History of head injury with evidence of brain injury or loss of consciousness for \> 60 minutes or cognitive sequelae
* Untreated or current episode of depression (answering positively to either of the two screening questions from the PHQ-9 (Kroenke, et al., 2001)
* Self-reported sleep disorders that could influence cognitive functioning including sleep apnea and and narcolepsy
* History of Axis I psychiatric disorder (DSM-IV), major affective disorder (untreated), bipolar disorder, schizophrenia disorder (DSM-IV) or substance use disorders (self reported and/or stated in medical record)
* History of schizophrenia, bipolar disorder or substance use disorders
* Patient is unwilling to undergo fMRI component if selected
* Patient has undergone previous chemotherapy treatment
-Participant has Documented evidence of severe cognitive compromise (Blessed- Orientation Memory Cognition Test score \> 11
* Participant has a history of neurological disorder with cognitive symptoms (e.g., Alzheimer's disease, Parkinson's disease, multiple sclerosis).
* Participant is pregnant as indicated by urine pregnancy test,
* As per self report participant is currently on daily medication for migraine, or , insulin dependent diabetes requiring administration by injection,
* As per self report participant has uncontrollable hypertension,
* As per self report, participant has a reported fear of enclosed spaces (Claustrophobia)
* As per self report, participant has any of the following items that preclude fMRI evaluation Cardiac pacemaker, Joint replacements, Aneurysm clips, Transdermal patched, Aortic clips Prosthesis, Intracranial bypass clips, Harrington rod , Coronary Artery bypass clips, Biostimulator, Renal Transplant Clips, Bone or joint pins, Other vascular clips or filters, Tissue expander ,Implanted neurostimulators, Metal mesh, Artificial heart valve, Stents, Insulin pump, Wire structures, Electrodes, Shrapnel/bullets, Hearing Aids implant, Implanted electrical devices, IUD, Metal in eyes, Shunts, Ocular Implants, Hair extensions, Hair implants, Tattoos above the waist, Any possible metal in body
* As per self report, participant has dentures, body jewelry or wig that they are unable to remove
* As per self report, participant has a history of head injury with evidence of brain injury or loss of consciousness for \> 60 minutes or cognitive sequelae
* As per self report, participant has untreated or current episode of depression (answering positively to either of the two screening questions from the PHQ-9 (Kroenke, et al., 2001)
* As per self report, participant has sleep disorders that could influence cognitive functioning including sleep apnea and narcolepsy,
* As per self report, participant has history of Axis I psychiatric disorder (DSM-IV), major affective disorder (untreated), bipolar disorder, schizophrenia disorder (DSM-IV) or substance use disorders
* As per self report, participant has undergone previous chemotherapy treatment.
18 Years
70 Years
FEMALE
Yes
Sponsors
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Weill Medical College of Cornell University
OTHER
The City College of New York
OTHER
Brigham and Women's Hospital
OTHER
Biomedical Engineering Newark College of Engineering New Jersey Institute of Technology
UNKNOWN
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Tim Ahles, PhD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Cancer Center
New York, New York, United States
Countries
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Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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07-130
Identifier Type: -
Identifier Source: org_study_id